V501 Efficacy Study in Women Aged 18 to 26 (V501-027)

HPV Infections Clinical Trial

Official title:

V501 Phase II Efficacy Study in Women Aged 18 to 26

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378560
• Other study ID #: V501-027
• Secondary ID: 2006_032
• Status: Completed
• Phase: Phase 2
• First received: September 18, 2006
• Last updated: March 23, 2015
• Start date: June 2006
• Est. completion date: September 2009

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1021
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 26 Years

Eligibility

Inclusion Criteria:

• Female Subject Aged 18 To 26 Years

• With 1-4 Lifetime Sexual Partners

Exclusion Criteria:

• Male Subject

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HPV Infections

Intervention

Biological:
• Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
V501; Gardasil, 0.5 ml injection in 3 dosing regimen
• Comparator: Placebo
Placebo 0.5 ml injection in 3 dosing regimen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Yoshikawa H, Ebihara K, Tanaka Y, Noda K. Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years. Cancer Sci. 2013 Apr;104(4):465-72. doi: 10.1111/cas.12106. Epub 2013 Mar 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype	Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.	Over 30 months	No
Secondary	Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)	Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group.; The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0".	At one month after completed vaccination series (Month 7)	No
Secondary	Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)	Month 7 HPV cLIA Geometric Mean Titers by vaccine group.; The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0".	At one month after completed vaccination series (Month 7)	No
Secondary	Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)	Month 7 HPV cLIA Geometric Mean Titers by vaccine group.; The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0".	At one month after completed vaccination series (Month 7)	No
Secondary	Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)	Month 7 HPV cLIA Geometric Mean Titers by vaccine group.; The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0".	At one month after completed vaccination series (Month 7)	No